Hearing Loss, Age-Related
Conditions
Keywords
hearing loss, communication, social participation
Brief summary
Amplification is a well-established, evidence-based front-line treatment for those with impaired communication secondary to Age Related Hearing Loss (ARHL). ARHL is the most prevalent cause of communication impairment among older adults. The challenge in treating ARHL is identifying a care model that effectively promotes adherence to individualized-treatment recommendations allowing the end-user to self-manage hearing loss with appropriate support. This proposal compares the two most common models of care for ARHL provided to adults in assisted living/personal care communities. The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility. The Engage Model is a chronic care approach to support hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist.
Detailed description
The study is employing an open cohort stepped-wedge cluster randomized design with a phased, randomized roll out. The stepped wedge design is a useful design for the evaluation of complex health care interventions particularly when the intervention is believed to be beneficial with minimal risk. This design is increasingly being used to evaluate interventions involving health care delivery and has several advantages: 1. allowing the clinical teams to roll out the intervention in a small number of facilities in a timely, systematic manner (interventions are not part of the research protocol) 2. possibly increasing participation and buy-in since all facilities will eventually implement the intervention during the study 3. possible increase in statistical power compared to a cluster randomized trial due to increase in data collection and within cluster comparisons. Our intervention is applied at the facility level (cluster) but the primary outcomes are obtained at the resident level. In this open cohort design, all residents in a facility are identified to participate but some may leave the facility and others will move into the facility over the course of the study. The interventions are standard care at UPMC and are at the facility and individual level regardless of participation in the research project by any individual. The 10 facilities participating in the study all currently receive the Consult Model of care. These same facilities are targeted to receive the Engage Model of care over the next three years as part of the standard care in these facilities. Residents enrolled in the study during any time period will be followed until the end of the study or until they are no longer a resident of the facility, whichever comes first. This implies that crossover to the intervention is not only at the facility level but also the resident level. Once the intervention is available at a facility, residents will be exposed to the intervention continuously regardless of enrollment for the study measures. The resident level outcomes of satisfaction with social participation and hearing-specific HRQoL will be measured every 5 months for the duration of the study. In addition, staff satisfaction and family burden will be surveyed every 5 months. NOTE: The clinicaltrials.gov record was updated after data collection ended to correct the study arms and interventions. The study arms were originally and incorrectly documented in clinicaltrials.gov as the resident, caregiver, and staff cohorts rather than the interventions.
Interventions
The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.
The Engage Model is a chronic care approach to supportive hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist.
Sponsors
Study design
Masking description
The data collectors will be masked to which phase the facility is in.
Intervention model description
Open cohort stepped-wedge cluster randomized design with a phased, randomized roll out
Eligibility
Inclusion criteria
* Willingness to participate and * Being a resident, staff member or family member of a resident at one of the participating Assisted Living/Personal Care Facilities.
Exclusion criteria
* Unwillingness to participate * Not being a Resident, staff member or family member of a resident at one of eight Assisted Living/Personal Care Facilities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Social Participation | Baseline (T0), at 5 (T1), 10 (T2), 15 (T3), 20 (T4) and 25 (T5) months | PROMIS Satisfaction with Participation in Discretionary Social Activities SF7a self-reported contentment with leisure interests and relationships with friends. T- scores are provided ranging from 27 to 65.6 where higher scores indicate more satisfaction (50 indicates the population mean with a standard deviation of 10). |
| Hearing-Specific Health-Related Quality of Life | Baseline, at 5, 10, 15, 20 and 25 months | Hearing Handicap Inventory for the Elderly captures social and emotional hearing handicap. 10 items with responses scored 0, 2, and 4 for 'No', 'Sometimes', and 'Yes'; min total score is 0 and maximum is 40. Higher scores indicate worse impact of hearing difficulties on activities and participation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family Burden | Baseline, at 5, 10, 15, 20 and 25 months | Zarit Burden Interview is a 4-item questionnaire that measures caregiver burden. The 4 items each have responses ranging from 0='Never' to 4='Nearly Always'. Item responses are summed to produce the total score that ranges from 0 to 16 with higher scores indicating more burden. |
| Staff Satisfaction | Baseline, at 5, 10, 15, 20 and 25 months | Michigan Organizational Assessment Questionnaire (MOAQ) is a 3-item questionnaire that measures satisfaction with one's job. Items have responses ranging from 1='Agree Strongly' to 6='Disagree Strongly'. The combined score is the average of the 3 items with one item reverse scored. Higher scores indicate less satisfaction. |
Countries
United States
Participant flow
Recruitment details
The study was an open cohort stepped wedge design with continuous recruitment and enrollment. Residents were enrolled at Time Period 0 but could be enrolled at any time period of the study due to being a new resident of the facility or being interested at the time period they were approached. The protocol enrollment reflects the total number enrolled at all 10 facilities across 6 time points (Time Periods 0-5).
Pre-assignment details
Available family members of residents in the study and staff in the facilities were asked to complete surveys for the secondary outcomes during each data collection period. These individuals were not tracked across time periods or documented for lost-to-follow-up or discontinuation from the study. The number of surveys and the corresponding results are presented in the secondary outcomes. No adverse event data were required to be collected for family members and staff.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (HearCARE Start T1) Participants in these facilities had the Consult Model for Time Period 0 then started the HearCARE program at Time Period 1 and continued with the HearCARE program through Time Period 5. | 162 |
| Group 2 (HearCARE Start T2) Participants in these facilities had the Consult Model for Time Periods 0 and 1 then started the HearCARE program at Time Period 2 and continued with the HearCARE program through Time Period 5. | 133 |
| Group 3 (HearCARE Start T3) Participants in these facilities had the Consult Model for Time Periods 0, 1 and 2 then started the HearCARE program at Time Period 3 and continued with the HearCARE program through Time Period 5. | 165 |
| Group 4 (HearCARE Start T4) Participants in these facilities had the Consult Model for Time Periods 0, 1, 2, and 3 then started the HearCARE program at Time Period 4 and continued with the HearCARE program through Time Period 5. | 123 |
| Group 5 (HearCARE Start T5) Participants in these facilities had the Consult Model for Time Periods 0-4 then started the HearCARE program at Time Period 5. | 101 |
| Total | 684 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Time Period 0 | Discontinued due to death or moving to higher level of care | 15 | 6 | 19 | 9 | 8 |
| Time Period 1 | Discontinued due to death or moving to higher level of care | 13 | 14 | 9 | 15 | 14 |
| Time Period 1 | Missing follow up | 1 | 3 | 1 | 3 | 2 |
| Time Period 2 | Discontinued due to death or moved to higher level of care | 15 | 8 | 20 | 15 | 8 |
| Time Period 2 | Missing follow up | 1 | 8 | 7 | 0 | 1 |
| Time Period 3 | Discontinued due to death or moved to higher level of care | 5 | 4 | 11 | 3 | 3 |
| Time Period 3 | Missing follow up | 8 | 6 | 4 | 3 | 0 |
| Time Period 4 | Discontinued due to death or moved to higher level of care | 2 | 3 | 9 | 1 | 9 |
| Time Period 4 | Missing follow up | 17 | 3 | 4 | 2 | 1 |
| Time Period 5 | Missing follow up | 11 | 8 | 12 | 3 | 11 |
Baseline characteristics
| Characteristic | Group 1 (HearCARE Start T1) | Group 2 (HearCARE Start T2) | Group 3 (HearCARE Start T3) | Group 4 (HearCARE Start T4) | Group 5 (HearCARE Start T5) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 89.3 years STANDARD_DEVIATION 7.8 | 87.8 years STANDARD_DEVIATION 7.1 | 87.3 years STANDARD_DEVIATION 8.3 | 89.0 years STANDARD_DEVIATION 8.4 | 83.8 years STANDARD_DEVIATION 8.6 | 87.7 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 161 Participants | 133 Participants | 165 Participants | 123 Participants | 101 Participants | 683 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hearing Handicap Inventory at Enrollment | 8.2 units on a scale STANDARD_DEVIATION 9.2 | 9.0 units on a scale STANDARD_DEVIATION 9 | 8.6 units on a scale STANDARD_DEVIATION 8.9 | 8.0 units on a scale STANDARD_DEVIATION 9.5 | 6.5 units on a scale STANDARD_DEVIATION 8.4 | 8.2 units on a scale STANDARD_DEVIATION 9 |
| PROMIS Participation at Enrollment | 49.4 T-score STANDARD_DEVIATION 7.1 | 50.6 T-score STANDARD_DEVIATION 8.1 | 49.9 T-score STANDARD_DEVIATION 8.8 | 48.1 T-score STANDARD_DEVIATION 7.2 | 49.8 T-score STANDARD_DEVIATION 7.3 | 49.6 T-score STANDARD_DEVIATION 7.8 |
| Pure tone average left side | 43.6 decibels STANDARD_DEVIATION 14.8 | 47.3 decibels STANDARD_DEVIATION 15.8 | 44.1 decibels STANDARD_DEVIATION 17 | 47.0 decibels STANDARD_DEVIATION 14.9 | 40.7 decibels STANDARD_DEVIATION 14.3 | 44.3 decibels STANDARD_DEVIATION 15.6 |
| Pure tone average right side | 43.5 decibels STANDARD_DEVIATION 14.2 | 47.0 decibels STANDARD_DEVIATION 15.8 | 44.1 decibels STANDARD_DEVIATION 17.5 | 47.6 decibels STANDARD_DEVIATION 17 | 39.5 decibels STANDARD_DEVIATION 14 | 44.0 decibels STANDARD_DEVIATION 15.9 |
| Race/Ethnicity, Customized Not Reported | 3 participants | 7 participants | 2 participants | 5 participants | 9 participants | 26 participants |
| Race/Ethnicity, Customized Not White | 4 participants | 6 participants | 3 participants | 2 participants | 0 participants | 15 participants |
| Race/Ethnicity, Customized White | 155 participants | 120 participants | 160 participants | 116 participants | 92 participants | 643 participants |
| Region of Enrollment United States | 162 participants | 133 participants | 165 participants | 123 participants | 101 participants | 684 participants |
| Sex: Female, Male Female | 123 Participants | 96 Participants | 126 Participants | 89 Participants | 61 Participants | 495 Participants |
| Sex: Female, Male Male | 39 Participants | 37 Participants | 39 Participants | 34 Participants | 40 Participants | 189 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 25 / 162 | 23 / 133 | 53 / 165 | 20 / 123 | 24 / 101 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Hearing-Specific Health-Related Quality of Life
Hearing Handicap Inventory for the Elderly captures social and emotional hearing handicap. 10 items with responses scored 0, 2, and 4 for 'No', 'Sometimes', and 'Yes'; min total score is 0 and maximum is 40. Higher scores indicate worse impact of hearing difficulties on activities and participation.
Time frame: Baseline, at 5, 10, 15, 20 and 25 months
Population: The overall number of participants analyzed represents the number of unique participants who provided data across the time points. The number at each time point represents the number of participants who contributed survey data at that time point. Due to the open cohort nature of the trial, the number with survey data represents both those enrolled who did not leave the cohort and those with survey data entering the cohort (newly enrolled).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (HearCARE Start at T1) | Hearing-Specific Health-Related Quality of Life | Baseline (Time 0) | 10.2 score on a scale | Standard Deviation 11.2 |
| Group 1 (HearCARE Start at T1) | Hearing-Specific Health-Related Quality of Life | 5 months (Time 1) | 9.4 score on a scale | Standard Deviation 9.6 |
| Group 1 (HearCARE Start at T1) | Hearing-Specific Health-Related Quality of Life | 10 months (Time 2) | 8.9 score on a scale | Standard Deviation 8.8 |
| Group 1 (HearCARE Start at T1) | Hearing-Specific Health-Related Quality of Life | 15 months (Time 3) | 7.3 score on a scale | Standard Deviation 8.9 |
| Group 1 (HearCARE Start at T1) | Hearing-Specific Health-Related Quality of Life | 20 months (Time 4) | 6.9 score on a scale | Standard Deviation 8.3 |
| Group 1 (HearCARE Start at T1) | Hearing-Specific Health-Related Quality of Life | 25 months (Time 5) | 9.0 score on a scale | Standard Deviation 11 |
| Group 2 (HearCARE Start at T2) | Hearing-Specific Health-Related Quality of Life | 20 months (Time 4) | 8.5 score on a scale | Standard Deviation 8.3 |
| Group 2 (HearCARE Start at T2) | Hearing-Specific Health-Related Quality of Life | 25 months (Time 5) | 8.5 score on a scale | Standard Deviation 10 |
| Group 2 (HearCARE Start at T2) | Hearing-Specific Health-Related Quality of Life | Baseline (Time 0) | 10.6 score on a scale | Standard Deviation 9.6 |
| Group 2 (HearCARE Start at T2) | Hearing-Specific Health-Related Quality of Life | 10 months (Time 2) | 11.6 score on a scale | Standard Deviation 10.2 |
| Group 2 (HearCARE Start at T2) | Hearing-Specific Health-Related Quality of Life | 15 months (Time 3) | 9.8 score on a scale | Standard Deviation 10 |
| Group 2 (HearCARE Start at T2) | Hearing-Specific Health-Related Quality of Life | 5 months (Time 1) | 10.9 score on a scale | Standard Deviation 10.1 |
| Group 3 (HearCARE Start at T3) | Hearing-Specific Health-Related Quality of Life | 15 months (Time 3) | 9.5 score on a scale | Standard Deviation 9.2 |
| Group 3 (HearCARE Start at T3) | Hearing-Specific Health-Related Quality of Life | 20 months (Time 4) | 7.9 score on a scale | Standard Deviation 7.7 |
| Group 3 (HearCARE Start at T3) | Hearing-Specific Health-Related Quality of Life | Baseline (Time 0) | 9.2 score on a scale | Standard Deviation 10.2 |
| Group 3 (HearCARE Start at T3) | Hearing-Specific Health-Related Quality of Life | 10 months (Time 2) | 8.9 score on a scale | Standard Deviation 8.5 |
| Group 3 (HearCARE Start at T3) | Hearing-Specific Health-Related Quality of Life | 5 months (Time 1) | 9.4 score on a scale | Standard Deviation 9.2 |
| Group 3 (HearCARE Start at T3) | Hearing-Specific Health-Related Quality of Life | 25 months (Time 5) | 4.4 score on a scale | Standard Deviation 5 |
| Group 4 (HearCARE Start at T4) | Hearing-Specific Health-Related Quality of Life | 15 months (Time 3) | 10.1 score on a scale | Standard Deviation 9.5 |
| Group 4 (HearCARE Start at T4) | Hearing-Specific Health-Related Quality of Life | 5 months (Time 1) | 9.2 score on a scale | Standard Deviation 10.9 |
| Group 4 (HearCARE Start at T4) | Hearing-Specific Health-Related Quality of Life | 10 months (Time 2) | 9.2 score on a scale | Standard Deviation 9 |
| Group 4 (HearCARE Start at T4) | Hearing-Specific Health-Related Quality of Life | 25 months (Time 5) | 6.9 score on a scale | Standard Deviation 8.5 |
| Group 4 (HearCARE Start at T4) | Hearing-Specific Health-Related Quality of Life | 20 months (Time 4) | 9.7 score on a scale | Standard Deviation 8.9 |
| Group 4 (HearCARE Start at T4) | Hearing-Specific Health-Related Quality of Life | Baseline (Time 0) | 7.5 score on a scale | Standard Deviation 8.9 |
| Group 5 (HearCARE Start at T5) | Hearing-Specific Health-Related Quality of Life | 20 months (Time 4) | 7.0 score on a scale | Standard Deviation 8.8 |
| Group 5 (HearCARE Start at T5) | Hearing-Specific Health-Related Quality of Life | 10 months (Time 2) | 5.6 score on a scale | Standard Deviation 7 |
| Group 5 (HearCARE Start at T5) | Hearing-Specific Health-Related Quality of Life | 5 months (Time 1) | 8.9 score on a scale | Standard Deviation 9.1 |
| Group 5 (HearCARE Start at T5) | Hearing-Specific Health-Related Quality of Life | 25 months (Time 5) | 5.6 score on a scale | Standard Deviation 8.6 |
| Group 5 (HearCARE Start at T5) | Hearing-Specific Health-Related Quality of Life | 15 months (Time 3) | 6.7 score on a scale | Standard Deviation 8.5 |
| Group 5 (HearCARE Start at T5) | Hearing-Specific Health-Related Quality of Life | Baseline (Time 0) | 8.1 score on a scale | Standard Deviation 9.4 |
Satisfaction With Social Participation
PROMIS Satisfaction with Participation in Discretionary Social Activities SF7a self-reported contentment with leisure interests and relationships with friends. T- scores are provided ranging from 27 to 65.6 where higher scores indicate more satisfaction (50 indicates the population mean with a standard deviation of 10).
Time frame: Baseline (T0), at 5 (T1), 10 (T2), 15 (T3), 20 (T4) and 25 (T5) months
Population: The overall number of participants analyzed represents the number of unique participants who provided data across the time points. The number at each time point represents the number of participants who contributed survey data at that time point. Due to the open cohort nature of the trial, the number with survey data represents both those enrolled who did not leave the cohort and those with survey data entering the cohort (newly enrolled).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (HearCARE Start at T1) | Satisfaction With Social Participation | Baseline (Time 0) | 49.7 T-score | Standard Deviation 7.9 |
| Group 1 (HearCARE Start at T1) | Satisfaction With Social Participation | 5 months (Time 1) | 49.7 T-score | Standard Deviation 7.8 |
| Group 1 (HearCARE Start at T1) | Satisfaction With Social Participation | 10 months (Time 2) | 48.1 T-score | Standard Deviation 7.1 |
| Group 1 (HearCARE Start at T1) | Satisfaction With Social Participation | 15 months (Time 3) | 52.0 T-score | Standard Deviation 7.1 |
| Group 1 (HearCARE Start at T1) | Satisfaction With Social Participation | 20 months (Time 4) | 49.4 T-score | Standard Deviation 5.6 |
| Group 1 (HearCARE Start at T1) | Satisfaction With Social Participation | 25 months (Time 5) | 49.1 T-score | Standard Deviation 7.3 |
| Group 2 (HearCARE Start at T2) | Satisfaction With Social Participation | 20 months (Time 4) | 49.0 T-score | Standard Deviation 7.1 |
| Group 2 (HearCARE Start at T2) | Satisfaction With Social Participation | 25 months (Time 5) | 48.2 T-score | Standard Deviation 7.8 |
| Group 2 (HearCARE Start at T2) | Satisfaction With Social Participation | Baseline (Time 0) | 52.8 T-score | Standard Deviation 8.9 |
| Group 2 (HearCARE Start at T2) | Satisfaction With Social Participation | 10 months (Time 2) | 47.6 T-score | Standard Deviation 6.1 |
| Group 2 (HearCARE Start at T2) | Satisfaction With Social Participation | 15 months (Time 3) | 47.1 T-score | Standard Deviation 6.5 |
| Group 2 (HearCARE Start at T2) | Satisfaction With Social Participation | 5 months (Time 1) | 48.4 T-score | Standard Deviation 6.7 |
| Group 3 (HearCARE Start at T3) | Satisfaction With Social Participation | 15 months (Time 3) | 45.4 T-score | Standard Deviation 6.2 |
| Group 3 (HearCARE Start at T3) | Satisfaction With Social Participation | 20 months (Time 4) | 47.2 T-score | Standard Deviation 6.3 |
| Group 3 (HearCARE Start at T3) | Satisfaction With Social Participation | Baseline (Time 0) | 51.2 T-score | Standard Deviation 10.3 |
| Group 3 (HearCARE Start at T3) | Satisfaction With Social Participation | 10 months (Time 2) | 49.4 T-score | Standard Deviation 7 |
| Group 3 (HearCARE Start at T3) | Satisfaction With Social Participation | 5 months (Time 1) | 47.6 T-score | Standard Deviation 8.7 |
| Group 3 (HearCARE Start at T3) | Satisfaction With Social Participation | 25 months (Time 5) | 49.6 T-score | Standard Deviation 8.2 |
| Group 4 (HearCARE Start at T4) | Satisfaction With Social Participation | 15 months (Time 3) | 49.9 T-score | Standard Deviation 8.1 |
| Group 4 (HearCARE Start at T4) | Satisfaction With Social Participation | 5 months (Time 1) | 48.1 T-score | Standard Deviation 5.6 |
| Group 4 (HearCARE Start at T4) | Satisfaction With Social Participation | 10 months (Time 2) | 48.6 T-score | Standard Deviation 7 |
| Group 4 (HearCARE Start at T4) | Satisfaction With Social Participation | 25 months (Time 5) | 47.4 T-score | Standard Deviation 7.2 |
| Group 4 (HearCARE Start at T4) | Satisfaction With Social Participation | 20 months (Time 4) | 48.1 T-score | Standard Deviation 6.8 |
| Group 4 (HearCARE Start at T4) | Satisfaction With Social Participation | Baseline (Time 0) | 49.4 T-score | Standard Deviation 6.6 |
| Group 5 (HearCARE Start at T5) | Satisfaction With Social Participation | 20 months (Time 4) | 48.2 T-score | Standard Deviation 6.4 |
| Group 5 (HearCARE Start at T5) | Satisfaction With Social Participation | 10 months (Time 2) | 47.4 T-score | Standard Deviation 6 |
| Group 5 (HearCARE Start at T5) | Satisfaction With Social Participation | 5 months (Time 1) | 48.1 T-score | Standard Deviation 7 |
| Group 5 (HearCARE Start at T5) | Satisfaction With Social Participation | 25 months (Time 5) | 48.9 T-score | Standard Deviation 6.7 |
| Group 5 (HearCARE Start at T5) | Satisfaction With Social Participation | 15 months (Time 3) | 48.4 T-score | Standard Deviation 6.6 |
| Group 5 (HearCARE Start at T5) | Satisfaction With Social Participation | Baseline (Time 0) | 51.7 T-score | Standard Deviation 7.6 |
Family Burden
Zarit Burden Interview is a 4-item questionnaire that measures caregiver burden. The 4 items each have responses ranging from 0='Never' to 4='Nearly Always'. Item responses are summed to produce the total score that ranges from 0 to 16 with higher scores indicating more burden.
Time frame: Baseline, at 5, 10, 15, 20 and 25 months
Population: The overall number of participants analyzed represents the number of unique participants who provided data across the time points. The number at each time point represents the number of participants who contributed survey data at that time point. Due to the open cohort nature of the trial, the number with survey data represents both those enrolled who did not leave the cohort and those with survey data entering the cohort (newly enrolled).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (HearCARE Start at T1) | Family Burden | Baseline (Time 0) | 5.5 score on a scale | Standard Deviation 3.7 |
| Group 1 (HearCARE Start at T1) | Family Burden | 5 months (Time 1) | 3.6 score on a scale | Standard Deviation 2.8 |
| Group 1 (HearCARE Start at T1) | Family Burden | 10 months (Time 2) | 3.9 score on a scale | Standard Deviation 2.8 |
| Group 1 (HearCARE Start at T1) | Family Burden | 15 months (Time 3) | 5.1 score on a scale | Standard Deviation 3.7 |
| Group 1 (HearCARE Start at T1) | Family Burden | 20 months (Time 4) | 4.8 score on a scale | Standard Deviation 2.8 |
| Group 1 (HearCARE Start at T1) | Family Burden | 25 months (Time 5) | 5.1 score on a scale | Standard Deviation 2.7 |
| Group 2 (HearCARE Start at T2) | Family Burden | 20 months (Time 4) | 3 score on a scale | Standard Deviation 2.8 |
| Group 2 (HearCARE Start at T2) | Family Burden | 25 months (Time 5) | 4.3 score on a scale | Standard Deviation 4 |
| Group 2 (HearCARE Start at T2) | Family Burden | Baseline (Time 0) | 4.4 score on a scale | Standard Deviation 3.4 |
| Group 2 (HearCARE Start at T2) | Family Burden | 10 months (Time 2) | 6.7 score on a scale | Standard Deviation 4.4 |
| Group 2 (HearCARE Start at T2) | Family Burden | 15 months (Time 3) | 5.2 score on a scale | Standard Deviation 4.6 |
| Group 2 (HearCARE Start at T2) | Family Burden | 5 months (Time 1) | 3.9 score on a scale | Standard Deviation 2.9 |
| Group 3 (HearCARE Start at T3) | Family Burden | 15 months (Time 3) | 5.4 score on a scale | Standard Deviation 3 |
| Group 3 (HearCARE Start at T3) | Family Burden | 20 months (Time 4) | 5.9 score on a scale | Standard Deviation 3.7 |
| Group 3 (HearCARE Start at T3) | Family Burden | Baseline (Time 0) | 5.4 score on a scale | Standard Deviation 3 |
| Group 3 (HearCARE Start at T3) | Family Burden | 10 months (Time 2) | 5.6 score on a scale | Standard Deviation 3.3 |
| Group 3 (HearCARE Start at T3) | Family Burden | 5 months (Time 1) | 4.5 score on a scale | Standard Deviation 3.1 |
| Group 3 (HearCARE Start at T3) | Family Burden | 25 months (Time 5) | 5.4 score on a scale | Standard Deviation 2.8 |
| Group 4 (HearCARE Start at T4) | Family Burden | 15 months (Time 3) | 4.1 score on a scale | Standard Deviation 3.8 |
| Group 4 (HearCARE Start at T4) | Family Burden | 5 months (Time 1) | 4.2 score on a scale | Standard Deviation 3.7 |
| Group 4 (HearCARE Start at T4) | Family Burden | 10 months (Time 2) | 4.8 score on a scale | Standard Deviation 3.7 |
| Group 4 (HearCARE Start at T4) | Family Burden | 25 months (Time 5) | 4.6 score on a scale | Standard Deviation 3.9 |
| Group 4 (HearCARE Start at T4) | Family Burden | 20 months (Time 4) | 5.0 score on a scale | Standard Deviation 3.5 |
| Group 4 (HearCARE Start at T4) | Family Burden | Baseline (Time 0) | 4.7 score on a scale | Standard Deviation 3.6 |
| Group 5 (HearCARE Start at T5) | Family Burden | 20 months (Time 4) | 5.3 score on a scale | Standard Deviation 3.9 |
| Group 5 (HearCARE Start at T5) | Family Burden | 10 months (Time 2) | 4.8 score on a scale | Standard Deviation 3.8 |
| Group 5 (HearCARE Start at T5) | Family Burden | 5 months (Time 1) | 4.6 score on a scale | Standard Deviation 3.4 |
| Group 5 (HearCARE Start at T5) | Family Burden | 25 months (Time 5) | 4.4 score on a scale | Standard Deviation 3.6 |
| Group 5 (HearCARE Start at T5) | Family Burden | 15 months (Time 3) | 5.0 score on a scale | Standard Deviation 4.8 |
| Group 5 (HearCARE Start at T5) | Family Burden | Baseline (Time 0) | 4.9 score on a scale | Standard Deviation 3 |
Staff Satisfaction
Michigan Organizational Assessment Questionnaire (MOAQ) is a 3-item questionnaire that measures satisfaction with one's job. Items have responses ranging from 1='Agree Strongly' to 6='Disagree Strongly'. The combined score is the average of the 3 items with one item reverse scored. Higher scores indicate less satisfaction.
Time frame: Baseline, at 5, 10, 15, 20 and 25 months
Population: The overall number of participants analyzed represents the number of unique participants who provided data across the time points. The number at each time point represents the number of participants who contributed survey data at that time point. Due to the open cohort nature of the trial, the number with survey data represents both those enrolled who did not leave the cohort and those with survey data entering the cohort (newly enrolled).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (HearCARE Start at T1) | Staff Satisfaction | Baseline (Time 0) | 2.1 score on a scale | Standard Deviation 1 |
| Group 1 (HearCARE Start at T1) | Staff Satisfaction | 5 months (Time 1) | 1.9 score on a scale | Standard Deviation 1 |
| Group 1 (HearCARE Start at T1) | Staff Satisfaction | 10 months (Time 2) | 1.7 score on a scale | Standard Deviation 0.8 |
| Group 1 (HearCARE Start at T1) | Staff Satisfaction | 15 months (Time 3) | 1.8 score on a scale | Standard Deviation 0.8 |
| Group 1 (HearCARE Start at T1) | Staff Satisfaction | 20 months (Time 4) | 1.8 score on a scale | Standard Deviation 1.1 |
| Group 1 (HearCARE Start at T1) | Staff Satisfaction | 25 months (Time 5) | 1.6 score on a scale | Standard Deviation 0.8 |
| Group 2 (HearCARE Start at T2) | Staff Satisfaction | 20 months (Time 4) | 1.5 score on a scale | Standard Deviation 0.8 |
| Group 2 (HearCARE Start at T2) | Staff Satisfaction | 25 months (Time 5) | 1.4 score on a scale | Standard Deviation 0.7 |
| Group 2 (HearCARE Start at T2) | Staff Satisfaction | Baseline (Time 0) | 1.3 score on a scale | Standard Deviation 0.5 |
| Group 2 (HearCARE Start at T2) | Staff Satisfaction | 10 months (Time 2) | 1.1 score on a scale | Standard Deviation 0.3 |
| Group 2 (HearCARE Start at T2) | Staff Satisfaction | 15 months (Time 3) | 1.3 score on a scale | Standard Deviation 0.6 |
| Group 2 (HearCARE Start at T2) | Staff Satisfaction | 5 months (Time 1) | 1.9 score on a scale | Standard Deviation 0.8 |
| Group 3 (HearCARE Start at T3) | Staff Satisfaction | 15 months (Time 3) | 2.0 score on a scale | Standard Deviation 1 |
| Group 3 (HearCARE Start at T3) | Staff Satisfaction | 20 months (Time 4) | 1.9 score on a scale | Standard Deviation 1.1 |
| Group 3 (HearCARE Start at T3) | Staff Satisfaction | Baseline (Time 0) | 1.6 score on a scale | Standard Deviation 0.8 |
| Group 3 (HearCARE Start at T3) | Staff Satisfaction | 10 months (Time 2) | 2.2 score on a scale | Standard Deviation 1.2 |
| Group 3 (HearCARE Start at T3) | Staff Satisfaction | 5 months (Time 1) | 1.6 score on a scale | Standard Deviation 0.7 |
| Group 3 (HearCARE Start at T3) | Staff Satisfaction | 25 months (Time 5) | 1.7 score on a scale | Standard Deviation 0.7 |
| Group 4 (HearCARE Start at T4) | Staff Satisfaction | 15 months (Time 3) | 1.7 score on a scale | Standard Deviation 0.8 |
| Group 4 (HearCARE Start at T4) | Staff Satisfaction | 5 months (Time 1) | 1.8 score on a scale | Standard Deviation 0.9 |
| Group 4 (HearCARE Start at T4) | Staff Satisfaction | 10 months (Time 2) | 1.4 score on a scale | Standard Deviation 0.5 |
| Group 4 (HearCARE Start at T4) | Staff Satisfaction | 25 months (Time 5) | 1.4 score on a scale | Standard Deviation 0.5 |
| Group 4 (HearCARE Start at T4) | Staff Satisfaction | 20 months (Time 4) | 1.4 score on a scale | Standard Deviation 0.6 |
| Group 4 (HearCARE Start at T4) | Staff Satisfaction | Baseline (Time 0) | 2.1 score on a scale | Standard Deviation 1 |
| Group 5 (HearCARE Start at T5) | Staff Satisfaction | 20 months (Time 4) | 1.8 score on a scale | Standard Deviation 0.8 |
| Group 5 (HearCARE Start at T5) | Staff Satisfaction | 10 months (Time 2) | 1.7 score on a scale | Standard Deviation 0 |
| Group 5 (HearCARE Start at T5) | Staff Satisfaction | 5 months (Time 1) | 1.8 score on a scale | Standard Deviation 0.7 |
| Group 5 (HearCARE Start at T5) | Staff Satisfaction | 25 months (Time 5) | 1.9 score on a scale | Standard Deviation 0.8 |
| Group 5 (HearCARE Start at T5) | Staff Satisfaction | 15 months (Time 3) | 2.1 score on a scale | Standard Deviation 0.9 |
| Group 5 (HearCARE Start at T5) | Staff Satisfaction | Baseline (Time 0) | 1.8 score on a scale | Standard Deviation 0.6 |